Posted by Michael Wonder on 17 Aug 2020
Myovant Sciences announces FDA acceptance of new drug application for once daily relugolix combination tablet for uterine fibroids
17 August 2020 - FDA sets target action date of 1 June 2021.
Myovant Sciences today announced that its new drug application for once-daily, oral relugolix combination tablet (relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg) for the treatment of women with heavy menstrual bleeding associated with uterine fibroids has been accepted for review by the U.S. FDA.
Relugolix (120 mg) is under priority review by the FDA for the treatment of men with advanced prostate cancer, with a target action date of 20 December 2020. Additionally, Myovant submitted a marketing authorisation application to the European Medicines Agency in March 2020 for relugolix combination tablet for the treatment of women with uterine fibroids.
